Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis

NCT ID: NCT02655939

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-11-30

Brief Summary

Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend contains individual ingredients which have been widely studied for its effectiveness in osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus reducing the pain and inflammation of the joint.

The two open-label studies have showed the effectiveness of the investigational product on OA. The 2 studies did not show any specific safety concern to be considered. The study demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results in the formulation.

The supplement has been manufactured in GMP certified manufacturing units in Germany and India under strict quality control check. Hence, quality of the supplement and batch to batch consistency is well assured.

Detailed Description

The purpose of this study is to assess the effect of Reflex Plus on osteoarthritis(OA) patients. The duration of the study is 12 / 24 weeks excluding the screening period of approximate 1 week. The test product being studied is Reflex Plus is composed of Collagen hydrolysate and Rosehip extract, it is a health supplement. It is expected to help in the building of cartilage for efficient joint functioning and relieving pain associated with arthritis It helps in cartilage protection and joint pain management.The primary endpoint of the study is the change in knee pain as measured by the WOMAC osteoarthritis (OA) index sum score between baseline and last visit in the comparison between IP and placebo.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Reflex Plus

Reflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration

Group Type: ACTIVE_COMPARATOR

Reflex Plus

Intervention Type: DIETARY_SUPPLEMENT

Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,

Placebo

Placebo Sachets to be taken once in a day Before breakfast for the study duration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Fructose,Orange flavor and sucralose

Interventions

Reflex Plus

Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Fructose,Orange flavor and sucralose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male and Female, aged ≥ 50 yrs and ≤ 70 yrs, with BMI<30.
• WOMAC pain score, between 8-16 on a scale of 0 to 20.
• Diagnosis confirmed of Gonarthrosis, by clinical and radiological means by Jaeger-Wirth score ≥2.
• Females to be included in the study should have reached menopause.
• Subjects willing to stop the restricted supplements and medications prior to inclusion in study and even during the study.
• Subjects using topical applications and rescue medication willing to stop the use 48 hours prior to all assessment.
• Subjects with Fasting blood glucose level ≤ 140 and Systolic blood pressure ≤ 160 mm of Hg and diastolic blood pressure ≤ 100 mm of hg.
• Subjects willing to adhere to protocol and complete subject diary.
• Patient willing and able to provide signed informed consent.

Exclusion Criteria

• Knee pain or functional impairment of the knee joint from causes other than osteoarthritis.
• Peripheral arterial occlusive disease
• Acute meniscus injuries
• Rheumatoid Arthritis
• Infection-associated arthritis
• Coxarthrosis
• Bony injuries of lower extremities(e.g. femoral neck fracture) in the last 12 months

Herniated Spinal Disc

• Any other severe organic and/or systemic diseases (e.g. renal, hepatic, cardiovascular) as per investigator's discretion
• Known allergies and/or sensitivities to ingredients of Reflex Plus™ or rescue medication
• Regular intake of products that may influence the study outcome, e.g.:

Nutritional Supplement such as vitamin supplements Mineral products, protein, amino acid concentrates Chondroprotective agents such as glucosamine sulfate, chondroitin sulfate, gelatin, hyaluronic acid and methylsulfonylmethane.

Fish oil capsules (omega 3 fatty acid capsules)

• Treatment with cartilage protection products in the last 3 months.
• Treatment (oral ingestion and injection) with steroidal and non-steroidal anti-inflammatory drugs with an exception of the following short-acting NSAID: acetylsalicylic acid, diclofenac, ibuprofen, celecoxib; other analgesics e.g. paracetamol, metamizole and phenazone.
• Cortisone treatment within less than 3 weeks prior to study inclusion.
• Intake of Opioid analgesics.
• Intake of anticoagulants of the coumarin type, such as acenocoumarol and phenprocoumon.
• Simultaneous treatment of osteoarthritis of knee with magnetic therapy, shockwave therapy, acupuncture
• Smokers will be excluded from the study. Occasional smokers willing to abstain smoking during the study can be considered.
• History of drug and alcohol abuse.
• Simultaneous participation in another clinical trial or participation in such within the last 6 weeks.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fullife Healthcare Pvt Ltd

UNKNOWN

Sponsor Role: collaborator

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Sachin Dighe, B.A.M.S.

Role: STUDY_DIRECTOR

sachin.d@vediclifesciences.com

Locations

Mukund Hospital

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

FZ/150603/RFX+/OA

Identifier Type: -

Identifier Source: org_study_id